3-Trimethoxysilyl Propyldimethyl Octadecyl Ammonium …...What Is 3-(Trimethoxysilyl) Propyldimethyl...
Transcript of 3-Trimethoxysilyl Propyldimethyl Octadecyl Ammonium …...What Is 3-(Trimethoxysilyl) Propyldimethyl...
Proposed Re-evaluation Decision PRVD2010-09
3-Trimethoxysilyl Propyldimethyl
Octadecyl Ammonium Chloride
(publié aussi en français) 6 May 2010
This document is published by the Health Canada Pest Management Regulatory Agency. For further information, please contact:
Publications Internet: [email protected] Pest Management Regulatory Agency healthcanada.gc.ca/pmra Health Canada Facsimile: 613-736-3758 2720 Riverside Drive Information Service: A.L. 6605C 1-800-267-6315 or 613-736-3799 Ottawa, Ontario [email protected] K1A 0K9
HC Pub: 100180
ISBN: 978-1-100-15604-0 (978-1-100-15605-7
Catalogue number: H113-27/2010-9E (H113-27/2010-9E-PDF)
© Her Majesty the Queen in Right of Canada, represented by the Minister of Health Canada, 2010
All rights reserved. No part of this information (publication or product) may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording or otherwise, or stored in a retrieval system, without prior written
permission of the Minister of Public Works and Government Services Canada, Ottawa, Ontario K1A 0S5.
Table of Contents
Overview ......................................................................................................................................... 1
What Is the Proposed Re-evaluation Decision? .......................................................................... 1
What Does Health Canada Consider When Making a Re-evaluation Decision? ........................ 1
What Is 3-(Trimethoxysilyl) Propyldimethyl Octadecyl Ammonium Chloride? ........................ 2
Health Considerations.................................................................................................................. 3
Environmental Considerations .................................................................................................... 3
Measures to Minimize Risk ......................................................................................................... 3
Next Steps .................................................................................................................................... 4
Science Evaluation .......................................................................................................................... 5
1.0 Introduction ......................................................................................................................... 5
2.0 The Technical Grade Active Ingredient, Its Properties and Uses ....................................... 5
2.1 Identity of the Technical Grade Active Ingredient ..............................................................5
2.2 Physical and Chemical Properties of the Technical Grade Active Ingredient .................... 6
2.3 Comparison of Use Patterns in Canada and the United States ........................................... 6
3.0 Impact on Human Health and the Environment ................................................................. 7
3.1 Human Health ......................................................................................................................7
3.1.1 Occupational Exposure and Risk Assessment ............................................................. 8
3.1.2 Non-Occupational Exposure and Risk Assessment .....................................................8
3.1.3 Cumulative Effects ..................................................................................................... 9
3.2 Environment ........................................................................................................................9
3.2.1 Environmental Risk Assessment. ................................................................................ 9
3.3 Pest Control Product Policy Considerations ..................................................................... 10
3.3.1 Toxic Substances Management Policy Considerations ............................................ 10
3.3.2 Contaminants and Formulants of Health or Environmental Concern ....................... 10
4.0 Incident Reports ................................................................................................................ 11
5.0 Organisation for Economic Co-operation and Development Status of this Active
Ingredient .......................................................................................................................... 11
6.0 Proposed Re-evaluation Decision ..................................................................................... 11
7.0 Supporting Documentation ............................................................................................... 11
List of Abbreviations .................................................................................................................... 13
Appendix I Registered Products Containing 3-(trimethoxysilyl) propyldimethyl octadecyl
ammonium chloride as of 3 January 2010 ................................................................ 15
Appendix II Label Amendments for Products Containing 3-(Trimethoxysilyl)
Propyldimethyl Octadecyl Ammonium Chloride ................................................. 17
References ..................................................................................................................................... 19
Proposed Re-evaluation Decision – PRVD2010-09
Proposed Re-evaluation Decision - PRVD2010-09 Page 1
Overview
What Is the Proposed Re-evaluation Decision?
After a re-evaluation of the antimicrobial 3-(trimethoxysilyl) propyldimethyl octadecyl
ammonium chloride, Health Canada’s Pest Management Regulatory Agency (PMRA), under the
authority of the Pest Control Products Act and Regulations, is proposing continued registration
for the sale and use of products containing this active ingredient in Canada.
An evaluation of available scientific information found that products containing
3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride do not present unacceptable
risks to human health or the environment when used according to label directions. As a condition
of the continued registration of 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium
chloride uses, new risk-reduction measures must be included on the labels of all products. No
additional data are being requested at this time.
This proposal affects all end-use products containing this active ingredient registered in Canada.
Once the final re-evaluation decision is made, the registrants will be instructed on how to address
any new requirements.
This Proposed Re-evaluation Decision is a consultation document1
that summarizes the science
evaluation for 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride and presents the
reasons for the proposed re-evaluation decision. It also proposes additional risk-reduction
measures to further protect human health and the environment.
The information is presented in two parts. The Overview describes the regulatory process and
key points of the evaluation, while the Science Evaluation provides detailed technical
information on the assessment of 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium
chloride.
The PMRA will accept written comments on this proposal up to 45 days from the date of
publication of this document. Please forward all comments to Publications (please see contact
information indicated on the cover page of this document).
What Does Health Canada Consider When Making a Re-evaluation Decision?
The PMRA’s pesticide re-evaluation program considers potential risks, as well as value, of
pesticide products to ensure they meet modern standards established to protect human health and
the environment. Regulatory Directive DIR2001-03, PMRA Re-evaluation Program, presents the
details of the re-evaluation activities and program structure.
1 “Consultation statement” as required by subsection 28(2) of the Pest Control Products Act.
Proposed Re-evaluation Decision - PRVD2010-09 Page 2
The active ingredient, 3-(Trimethoxysilyl) propyldimethyl octadecyl ammonium chloride, one
of the active ingredients in the current re-evaluation cycle, has been re-evaluated under
Re-evaluation Program 1. This program relies as much as possible on foreign reviews, typically
United States Environmental Protection Agency (USEPA) Reregistration Eligibility Decision
(RED) documents. For products to be re-evaluated under Program 1, the foreign review must
meet the following conditions:
• it covers the main science areas, such as human health and the environment, that are
necessary for Canadian re-evaluation decisions;
• it addresses the active ingredient and the main formulation types registered in Canada;
and
• it is relevant to registered Canadian uses.
Given the outcome of foreign reviews and a review of the chemistry of Canadian products, the
PMRA will propose a re-evaluation decision and appropriate risk-reduction measures for
Canadian uses of an active ingredient. In this decision, the PMRA takes into account the
Canadian use pattern and issues (e.g., the federal Toxic Substances Management Policy
[TSMP]).
Based on the health and environmental risk assessments published in the 2007 Reregistration
Eligibility Decision document, the USEPA concluded that 3-(trimethoxysilyl) propyldimethyl
octadecyl ammonium chloride was eligible for reregistration provided risk-reduction measures
were adopted. The PMRA compared the American and Canadian use patterns and found the
USEPA assessments described in this RED were an adequate basis for the proposed Canadian
re-evaluation decision.
For more details on the information presented in this overview, please refer to the Science
Evaluation section of this consultation document.
What Is 3-(Trimethoxysilyl) Propyldimethyl Octadecyl Ammonium Chloride?
The active ingredient, 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride,
is an antimicrobial active ingredient that is used as a material preservative. It is used in or
on textiles, towelettes, tissue wipes, fibers, roofing materials, filters, filter materials,
foam, fibreglass, plastic products, rubber products, fan/humidifier belts, and hard indoor
surfaces. This chemical is handled by professional workers and is added during the
manufacturing process of treated articles. In addition, this active ingredient may be
applied in buildings to control microbial growth on surfaces.
Proposed Re-evaluation Decision - PRVD2010-09 Page 3
Health Considerations
Can Approved Uses of this Active Ingredient Affect Human Health?
The active ingredient, 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium
chloride, is unlikely to affect your health when used according to the revised label
directions.
People could potentially be exposed to this active ingredient when applying this active
ingredient, through post application exposure when re-entering treated sites and handling
treated articles or through residential exposure (i.e., coming into contact with treated
articles). The PMRA considers two key factors when assessing health risks: the levels at
which no health effects occur and the levels to which people may be exposed. The dose
levels used to assess risks are established to protect the most sensitive human population
(for example, children and nursing mothers). Only uses for which exposure is well below
levels that cause no effects in animal testing are considered acceptable for continued
registration.
The USEPA concluded that 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium
chloride was unlikely to affect human health provided that risk reduction measures were
implemented. These conclusions apply to the Canadian situation, and equivalent risk
reduction measures are required by the PMRA.
Environmental Considerations
What Happens When 3-(Trimethoxysilyl) Propyldimethyl Octadecyl Ammonium Chloride
Is Introduced Into the Environment?
The active, 3-(Trimethoxysilyl) propyldimethyl octadecyl ammonium chloride is
unlikely to affect non-target organisms when used according to the revised label
directions.
The USEPA concluded that indoor uses of 3-(trimethoxysilyl) propyldimethyl octadecyl
ammonium chloride would result in minimal environmental exposure, and were unlikely
to affect non-target organisms. These conclusions apply to the Canadian situation.
Measures to Minimize Risk
Labels of registered pesticide products include specific instructions for use. Directions include
risk-reduction measures to protect human health and the environment. These directions must be
followed by law. As a result of the re-evaluation of 3-(trimethoxysilyl) propyldimethyl octadecyl
ammonium chloride, the PMRA proposes further risk-reduction measures for product labels.
Proposed Re-evaluation Decision - PRVD2010-09 Page 4
Human Health
• Additional personal protective equipment to protect workers
• Limit use of this active ingredient to materials and products that do not come into direct
contact with food or feed
• Additional warning signals, advisory and basic hygiene statements on end-use product
labels
Environment
• Update label statements to further protect the environment from effluent discharge
A submission to request label revisions will be required within 90 days of finalization of the
re-evaluation decision.
Next Steps
Before making a final re-evaluation decision, the PMRA will consider all comments received
from the public in response to this consultation document. The PMRA will then publish a
Re-evaluation Decision2 document that will include the decision, the reasons for it, a summary of
comments received on the proposed decision and the Pest Management Regulatory Agency’s
response to these comments.
2 “Decision statement” as required by subsection 28(5) of the Pest Control Products Act.
Proposed Re-evaluation Decision - PRVD2010-09 Page 5
Science Evaluation
1.0 Introduction
The active ingredient, 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride, is
currently registered in Canada as a material preservative. This active ingredient acts as an
antimicrobial added to various industrial processes to control microbial growth. It is also used in
buildings to control microbial growth on surfaces.
Following the re-evaluation announcement for 3-(trimethoxysilyl) propyldimethyl octadecyl
ammonium chloride, the registrant of the technical grade active ingredient in Canada indicated
that they intended to provide continued support for all uses included on the labels of commercial
class end-use products in Canada.
The Pest Management Regulatory Agency (PMRA) used recent assessments of
3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride from the United States
Environmental Protection Agency (USEPA). The USEPA Reregistration Eligibility Decision
(RED) document for Trimethoxysilyl Quaternary Ammonium Chloride compounds, dated
25 September 2007, as well as other information on the regulatory status of this active ingredient
in the United States can be found on the USEPA Pesticide Registration Status page at
www.epa.gov/pesticides/reregistration/status.htm.
2.0 The Technical Grade Active Ingredient, Its Properties and Uses
2.1 Identity of the Technical Grade Active Ingredient
Common name 3-(Trimethoxysilyl)-propyldimethyloctadecyl
ammonium chloride
Function Antimicrobial active ingredient
Chemical family Quaternary ammonium chloride salt
Chemical name
1 International Union of
Pure and Applied
Chemistry
2 Chemical Abstracts
Service
Chemical Abstracts Service
Registry Number
3-(Trimethoxysilyl)-propyldimethyloctadecyl
ammonium chloride
3-(Trimethoxysilyl)-propyldimethyloctadecyl
ammonium chloride
27668-52-6
Molecular formula C26H58ClNO3Si
Proposed Re-evaluation Decision - PRVD2010-09 Page 6
Structural formula OCH3 CH3
CH3O
Si (CH2)3 N+
(CH2)17 CH3
OCH3 CH3 Cl-
Molecular weight 496.28 atomic mass units
Purity of the technical grade active 72.1 % nominal
ingredient
Registration Number 23388
Based on the manufacturing process used, contaminants of human health or environmental
concern as identified in the Canada Gazette, Part II, Vol. 142, No. 13, SI/2008-67 (2008-06-25),
Section 2.13.4 of DIR98-04 and Appendix II of DIR99-03 (Toxic Substances Management
Policy Track 1 substances) are not expected to be present in this product.
2.2 Physical and Chemical Properties of the Technical Grade Active Ingredient
Property Result Interpretation
Vapour pressure 5.8 × 10-14
mmHg Low volatility
UV–visible spectrum No UV absorbing chromophore Phototransformation is unlikely
Solubility in water miscible Highly soluble in water
n-Octanol–water
partition coefficient
Log Kow < 3 Bioaccumulation unlikely
2.3 Comparison of Use Patterns in Canada and the United States
The chemical, 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride, is an
antimicrobial active ingredient that is used as a material preservative. It is used on textiles,
towelettes, tissue wipes, fibres, roofing materials, filters, filter materials, foam, fibreglass,
plastic products, rubber products, fan/humidifier belts, and hard indoor surfaces. Commercial
class end use products are formulated as a solution and a suspension. They are applied during
the manufacturing process of treated materials by brushing on, dipping, padding, soaking,
spraying, fogging or by using foam finishing techniques. In addition, it may be applied in
buildings by spraying or brushing the product onto surfaces.
The American and Canadian use patterns were compared. The Canadian formulation types of the
end-use products and the uses of 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium
chloride as a material preservative are among those registered in the United States. Based on this
comparison of use patterns, it was concluded that the USEPA RED for 3-(trimethoxysilyl)
propyldimethyl octadecyl ammonium chloride is an adequate basis for the re-evaluation of uses
of 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride in Canada.
Proposed Re-evaluation Decision - PRVD2010-09 Page 7
All current uses are being supported by the registrant and were, therefore, considered in the
re-evaluation of this active ingredient. Appendix I lists all 3-(trimethoxysilyl) propyldimethyl
octadecyl ammonium chloride products that are registered as of 3 January, 2010, under the
authority of the Pest Control Products Act.
3.0 Impact on Human Health and the Environment
In their 2007 RED, the USEPA concluded that the end-use products formulated with
3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride met the safety standard under
the American Federal Insecticide, Fungicide and Rodenticide Act and would not pose
unreasonable risks or adverse effects to humans and the environment if used according to the
amended product labels.
3.1 Human Health
Toxicology studies in laboratory animals describe potential health effects resulting from various
levels of exposure to a chemical and identify dose levels at which no effects are observed.
Unless there is evidence to the contrary, it is assumed that effects observed in animals are
relevant to humans and that humans are more sensitive to effects of a chemical than the most
sensitive animal species.
In Canada, exposure to 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride may
occur during the application of the pesticide product, through post application exposure when
re-entering treated sites and handling treated articles or through residential exposure (i.e. coming
into contact with treated articles, such as apparel, fibreglass, polyurethane foam, etc.).
Formulations containing 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride also
contain methanol. Workers may be exposed to methanol when handling the pesticide product or
through post application exposure (i.e., re-entering treated sites or handling treated articles before
the product has dried).
When assessing health risk, the PMRA considers two key factors: the levels at which no health
effects occur and the levels to which people may be exposed. The dose levels used to assess risks
are established to protect the most sensitive human population (for example, children and
nursing mothers).
Upon reviewing the available toxicity data, the USEPA concluded that there are no relevant
endpoints of toxicological concern for single or repeated oral or dermal exposure to
3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride. This conclusion is based on
the absence of systemic toxicity observed in subchronic and developmental studies conducted
with this chemical.
Proposed Re-evaluation Decision - PRVD2010-09 Page 8
3.1.1 Occupational Exposure and Risk Assessment
Occupational risk is estimated by comparing potential exposures with the most relevant endpoint
from toxicology studies. In Canada, workers can be exposed to 3-(trimethoxysilyl)
propyldimethyl octadecyl ammonium chloride and methanol when handling the pesticide
product or through post application exposure when handling treated products and when re-
entering a treated site.
3.1.1.1 Handler Exposure and Risk
The USEPA conducted a qualitative handler occupational exposure risk assessment and
concluded that although the potential for exposure to 3-(trimethoxysilyl) propyldimethyl
octadecyl ammonium chloride exists, no relevant endpoints of toxicological concern were
identified.
The RED adequately addressed the potential risk associated with the uses of products containing
3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride in Canada, and some of the
conclusions apply to the Canadian situation. Due to the potential for severe eye and skin
irritation of this active ingredient and the presence of methanol in end-use products, the PMRA
requires additional advisory label statements to further protect workers, including:
• additional personal protective equipment (nitrile, neoprene, butyl or latex rubber gloves);
• update of warning signals on current labels; and
• additional basic hygiene statements.
The proposed label amendments for products containing 3-(trimethoxysilyl) propyldimethyl
octadecyl ammonium chloride can be found in Appendix II.
3.1.1.2 Post Application Exposure and Risk
Post application occupational exposure is most likely to occur when handling treated product
and re-entering treated sites. No endpoint of toxicological concern was identified by the USEPA
for 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride. Based on these
conclusions, no risk reduction measures are required.
3.1.2 Non-Occupational Exposure and Risk Assessment
3.1.2.1 Residential Exposure
In the 2007 RED, it was concluded that there is potential for residential exposure to
3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride. However, no endpoint of
toxicological concern was identified and, therefore, residential exposure is not of concern.
The conclusions derived from the RED are considered relevant to the Canadian situation, and no
risk reduction measures are required.
Proposed Re-evaluation Decision - PRVD2010-09 Page 9
3.1.2.2 Exposure from Food and Drinking Water
There are no food or feed uses currently registered for 3-(trimethoxysilyl) propyldimethyl
octadecyl ammonium chloride in Canada. This chemical has not been granted a “No Objection
Letter” from Health Canada and, therefore, it is not permitted for use in packaging materials
intended for food contact (e.g., plastics). This active ingredient is a permitted incidental additive
for use in food processing plants on ceramic tiles for walls, provided that there is no direct
contact of these surfaces with food or feed.
The USEPA concluded that this chemical would not likely result in contamination of surface and
ground water, when used as directed. Therefore, exposure through the consumption of drinking
water is not expected.
The RED adequately addressed dietary exposure scenarios associated with the use of
3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride. The conclusions derived from
the RED are relevant to the Canadian situation. On this basis, it is concluded that dietary
exposures to this chemical are not of concern. Based on the absence of registered food and feed
uses in Canada, an additional advisory label statement prohibiting use of this active ingredient in
or on surfaces or manufactured goods intended for direct contact with food or feed is required on
all end-use products. Appendix II lists all of the proposed label amendments for
3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride.
3.1.2.3 Aggregate Risk Assessment
Aggregate risk combines the different routes of exposure (i.e., from food, drinking water and
residential exposures). Based on the use pattern, aggregate exposure is not expected.
3.1.3 Cumulative Effects
The USEPA has not determined whether 3-(trimethoxysilyl) propyldimethyl octadecyl
ammonium chloride has a common mechanism of toxicity with other substances or whether it
shares a toxic metabolite produced by other substances. Therefore, it was assumed that it does
not share a common mechanism of toxicity with other substances, and a cumulative risk
assessment was not required.
3.2 Environment
3.2.1 Environmental Risk Assessment
The USEPA concluded that adverse effects to non-target organisms are not anticipated from the
indoor use of 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride due to the low
likelihood of exposure. This active ingredient is practically non-toxic to birds and mammals,
moderately toxic to fish and highly toxic to freshwater aquatic invertebrates. The USEPA also
concluded that this active ingredient would undergo rapid hydrolysis and, based on the use
pattern, is not expected to impact surface or ground water.
Proposed Re-evaluation Decision - PRVD2010-09 Page 10
The RED adequately addressed risk to non-target organisms, and the conclusions derived from
the RED apply to the Canadian situation. Based on the PMRA general practices, advisory label
statements are required to further protect the environment. Appendix II lists all of the proposed
label amendments for 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride.
3.3 Pest Control Product Policy Considerations
3.3.1 Toxic Substances Management Policy Considerations
The Toxic Substances Management Policy is a federal government policy developed to provide
direction on the management of substances of concern that are released into the environment.
The Toxic Substances Management Policy calls for the virtual elimination of Track 1 substances
(those that meet all four criteria outlined in the policy, i.e., toxic or equivalent, predominantly
anthropogenic, persistent and bio-accumulative as defined by the Canadian Environmental
Protection Act).
During the re-evaluation process, 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium
chloride was assessed in accordance with the PMRA Regulatory Directive DIR99-03, The Pest
Management Regulatory Agency’s Strategy for Implementing the Toxic Substances Management
Policy, and evaluated against the Track 1 criteria for persistence and bioaccumulation. In order
for 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride or its transformation
products to meet Track 1 criteria, the criteria for both bioaccumulation and persistence (in one
media) must be met.
The active ingredient, 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride, was observed to have a half-life of less than 15 minutes in water, which is below the TSMP Track 1
cut-off criterion of 182 days. Further, volatilisation is not an important route of dissipation and,
long-range transport is unlikely based on vapour pressure (5.8x10-14
mm Hg). On this basis, it is
concluded that the use of 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride is not expected to result in the entry of Track 1 substances into the environment.
3.3.2 Contaminants and Formulants of Health or Environmental Concern
During the re-evaluation of 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride,
contaminants in the technical grade active ingredient are compared against the List of Pest
control Product Formulants and Contaminants of Health or Environmental Concern maintained
in the Canada Gazette. The list is used as described in the PMRA Notice of Intent NOI2005-01
and is based on existing policies and regulations including: DIR99-03; and DIR2006-02, and
taking into consideration the Ozone-depleting Substance Regulations, 1998, of the Canadian
Environmental Protection Act (substances designated under the Montreal Protocol). The PMRA
has reached the following conclusion:
• Technical grade 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride does not
contain any contaminants of health or environmental concern identified in the Canada
Gazette.
Proposed Re-evaluation Decision - PRVD2010-09 Page 11
4.0 Incident Reports
As of 26 April 2007, registrants are required by law to report incidents, including adverse effects
to health and the environment, to the PMRA. There were no incident reports submitted for 3-
(trimethoxysilyl) propyldimethyl octadecyl ammonium chloride as of 3 January 2010.
5.0 Organisation for Economic Co-operation and Development Status of
this Active Ingredient
Canada is part of the Organisation for Economic Co-operation and Development, which groups
30 member countries and provides governments with a setting in which to develop economic and
social policies to allow for consistency in practices across nations.
Currently available information indicates that 3-(trimethoxysilyl) propyldimethyl octadecyl
ammonium chloride is to undergo re-evaluation in the European Union, where it is currently
permitted for use as a material preservative.
The United States, assessed the registration of all uses of 3-(trimethoxysilyl) propyldimethyl
octadecyl ammonium chloride in 2007. The conclusions of the RED are the basis on which this
re-evaluation was conducted and are summarized in this document.
6.0 Proposed Re-evaluation Decision
The PMRA has determined that 3-(trimethoxysilyl) propyldimethyl octadecyl ammonium
chloride is acceptable for continued registration with the implementation of the proposed
risk-reduction measures. These measures are required to further protect human health and the
environment. The labels of Canadian end-use product must be amended to include the label
statements listed in Appendix II. A submission to implement label revisions will be required
within 90 days of finalization of the re-evaluation decision. No additional data are being
requested at this time.
7.0 Supporting Documentation
Pest Management Regulatory Agency documents, such as Regulatory Directive DIR2001-03,
can be found on the Pesticides and Pest Management portion of Health Canada’s website at
www.healthcanada.gc.ca/pmra. Pest Management Regulatory Agency documents are also
available through the Pest Management Information Service. Phone: 1-800-267-6315 within
Canada or 1-613-736-3799 outside Canada (long distance charges apply); fax: 613-736-3798;
e-mail: [email protected].
The federal Toxic Substances Management Policy is available through Environment Canada’s
website at www.ec.gc.ca/toxics.
Proposed Re-evaluation Decision - PRVD2010-09 Page 12
The USEPA Reregistration Eligibility Decision document for Trimethoxysilyl Quaternary
Ammonium Chloride Compounds is available on the USEPA Pesticide Registration Status page
at www.epa.gov/pesticides/reregistration/status.htm.
Proposed Re-evaluation Decision - PRVD2010-09 Page 13
List of Abbreviations
List of Abbreviations
Kow n-octanol–water partition coefficient
mm Hg millimetre mercury
PMRA Pest Management Regulatory Agency
RED Reregistration Eligibility Decision
USEPA United States Environmental Protection Agency
UV ultraviolet
Proposed Re-evaluation Decision - PRVD2010-09 Page 14
Appendix I
Appendix I Registered Products Containing 3-(trimethoxysilyl)
propyldimethyl octadecyl ammonium chloride as of
3 January 2010
Registration
Number
Marketing
Class
Registrant
Product Name Formulation
Type
Guarantee
(per cent)
23388 Technical Aegis Environmental
Management INC
AEM 5772-TA Antimicrobial
Agent
Suspension 72.1
15133 Commercial Aegis Environmental
Management INC
AEM 5700 Antimicrobial Solution 42.0
28541 Commercial Aegis Environmental
Management INC
AEM 5772-EP Antimicrobial Suspension 72.1
Proposed Re-evaluation Decision - PRVD2010-09 Page 15
Appendix II Label Amendments for Products Containing
Appendix II
3-(Trimethoxysilyl) Propyldimethyl Octadecyl Ammonium
Chloride
The label amendments presented below do not include all label requirements for individual
end-use products, such as first aid statements, disposal statements, precautionary statements and
supplementary protective equipment. Additional information on labels of currently registered
products should not be removed unless it contradicts the above label statements.
A submission to request label revisions will be required within 90 days of finalization of the
re-evaluation decision.
The labels of end-use products in Canada must be amended to include the following to further
protect human health and the environment.
I) The following must be included in the section DIRECTIONS FOR USE.
DO NOT use this product on manufactured products intended for food/feed contact
surfaces.
DO NOT contaminate irrigation or drinking water supplies or aquatic habitats by
cleaning of equipment or disposal of wastes.
II) The following must be included in the section PRECAUTIONS.
DANGER CORROSIVE. Causes irreversible eye damage and skin burns.
May be fatal if inhaled
May be harmful or fatal if swallowed or absorbed through the skin
Appropriate measures must be taken to prevent accumulation of hazardous
concentrations of methanol vapours in the work area
COMBUSTIBLE. DO NOT use or store near heat or open flame
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using
the toilet.
Launder clothing separately from other clothing before reuse. Discard clothing and other
absorbent materials that have been drenched or heavily contaminated with this product’s
concentrate. DO NOT reuse them.
Proposed Re-evaluation Decision - PRVD2010-09 Page 16
Appendix II
Users should remove personal protective equipment immediately after handling this
product. Wash the outside of the gloves before removing. Remove clothing immediately
if pesticide comes into contact with skin through soak clothing or spills. Wash skin
thoroughly and put on clean clothes.
Avoid touching eyes and face until you have washed your hands.
Never use the mouth to siphon product from containers or to blow out clogged lines,
nozzles, etc
Follow manufacturer's instructions for cleaning/maintaining personal protective
equipment (PPE). If no such instructions for washables exist, use detergent and hot water.
Keep and wash PPE separately from other laundry.
DO NOT apply this product in a way that will contact workers or other persons, either
directly or through drift. Only protected handlers may be in the area during application.
DO NOT get in eyes, on skin or on clothes
III) In the section titled PRECAUTIONS, replace “chemical resistant gloves” with “nitrile,
neoprene, butyl or latex gloves”
IV) In the section ENVIRONMENTAL HAZARDS, replace “toxic to fish” with “toxic to
aquatic organisms”.
Proposed Re-evaluation Decision - PRVD2010-09 Page 17
References
Studies considered in the Chemistry Assessment
A. LIST OF STUDIES/INFORMATION SUBMITTED BY REGISTRANT
References
PMRA
Document
Number
Reference
1463625 2006, Chemical Physical Properties, DACO: 2.14.1, 2.14.2, 2.14.3,
2.14.6
1463626 2007, Chemical Physical Properties, DACO: 2.14.10, 2.14.11,
2.14.12, 2.14.13, 2.14.14, 2.14.4, 2.14.7, 2.14.8, 2.14.9, 2.15
1545864 M. G. Hales, Dow Corning Corporation, Part 2 Product Chemistry
(LSS 92228)